Health Benefits of Vitamin D and Calcium in Women With PCOS (Polycystic Ovarian Syndrome)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Serum HbA1C at 3 Months
研究概览
简要总结
The investigators conducted a prospective un-blinded pilot study of Vitamin D plus Calcium (Ca) supplementation in overweight (BMI > 27) premenopausal women diagnosed with Polycystic Ovarian Syndrome (PCOS), as defined by the Rotterdam Criteria, 2003, and who were deficient in vitamin D as reflected by serum 25-hydroxy (25-OH) vitamin D (serum levels < 20 ng/mL).
详细描述
We had hypothesized that in women with PCOS, administering optimal daily doses of vitamin D3, as recommended by the National Academy of Sciences, 2000IU Cholecalciferol and 1000mg of calcium, both per oral (PO), over a three month period will improve their metabolic picture, and possibly hormone profile.
Over the course of the trial, after the first 5 subjects had completed 3 month intervention,we observed that daily 2000IU D3 dosing regime was inadequate in normalizing vitamin D status in the study population; the dosing regimen was therefore modified to include weekly supplementation with 50,000IU D2 in addition to daily dosing with 2000IU D3.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women (ages 18-40 years) with normal thyroid function and prolactin levels.
- •PCOS diagnosis based on Rotterdam criteria: presence of at least 2 of the following criteria:
- •oligomenorrhea-menstrual cycles > 35 day intervals
- •hyperandrogenemia (elevated serum testosterone [free or total] &/or androstenedione levels) or features of hyperandrogenism i.e. acne or hirsuitism [Ferriman-Gallaway score > 3]
- •polycystic ovaries on vaginal ultrasound as defined by ESHRE/ASRM criteria (ovarian volume ≥ 10mL or ≥ 12 follicles of diameter between 2-9mm in at least one ovary)
- •Overweight (BMI ≥ 27 Kg/m2)
- •Biochemical evidence of Vitamin D insufficiency (i.e. serum 25 OHD levels < 20ng/mL)
排除标准
- •Pregnancy
- •Known causes of oligomenorrhea other than PCOS, e.g. hypothyroidism/Cushing's Disease/late onset congenital adrenal hyperplasia (fasting 17-alphahydroxyprogesterone levels < 200ng/dL)
- •Use of hormonal treatment (birth control pill/patch/depot medroxyprogesterone/medroxyprogesterone) within 3 months of the study onset.
- •Use insulin sensitizers (metformin, sulfonylureas, TZDs, incretins) within 3 months of the study onset.
- •Use of lipid lowering agents or medications known to influence insulin sensitivity (e.g. niacin, corticosteroids, beta blockers, calcium channel blockers, thiazide diuretics) or influence serum androgens (estrogen, anti-androgens, androgens) within 3 months of the study onset.
- •Known history of renal calculi or current use of Calcium and Vitamin D supplements.
- •Spanish Speaking.
研究组 & 干预措施
Vitamin D plus Calcium (Ca) supplementation
干预措施: Vitamin D2 (Ergocalciferol) (Dietary Supplement)
Vitamin D plus Calcium (Ca) supplementation
干预措施: Medroxyprogesterone (Provera) (Drug)
Vitamin D plus Calcium (Ca) supplementation
干预措施: Vitamin D3 (Cholecalciferol) (Dietary Supplement)
Vitamin D plus Calcium (Ca) supplementation
干预措施: Elemental Calcium (Dietary Supplement)
结局指标
主要结局
Serum HbA1C at 3 Months
时间窗: Completion
Fasting HbA1C levels at study completion after 3 month treatment
Fasting Insulin Levels at Study Completion After 3 Month Treatment
时间窗: 3 months intervention
Fasting insulin levels at study completion after 3 month treatment
Fasting Glucose Levels at Completion of Treatment, at 3 Months
时间窗: 3 months
Fasting glucose levels drawn after 3 months completion during oral GTT
AUC (Area Under a Curve at 0, 0.5, 1, 1.5 and 2 Hours) Insulin During 2 Hour GTT at Completion, at 3 Months
时间窗: 3 months
Following 3 months intervention, AUC insulin was determined during 2 hour oral GTT
AUC (Area Under the Curve at 0, 0.5, 1, 1.5 and 2 Hours) During Oral GTT at Completion, at 3 Months
时间窗: 3 months
AUC (Area under the curve at 0, 0.5, 1, 1.5 and 2 hours)for glucose was determined at completion of 3 months intervention for 2 hour oral GTT
次要结局
- Serum Levels of C-reactive Protein at Completion of 3 Months Treatment(3 months)